Welcome to our dedicated page for Assembly Bioscie news (Ticker: ASMB), a resource for investors and traders seeking the latest updates and insights on Assembly Bioscie stock.
Assembly Biosciences, Inc. (ASMB) news on Stock Titan centers on the company’s progress in developing small-molecule therapeutics for serious viral diseases. Assembly Bio describes itself as a biotechnology company focused on herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections, and its news flow reflects clinical, scientific and corporate developments across these areas.
Investors following ASMB news can expect regular updates on clinical trial milestones. Recent press releases detail interim Phase 1b results for long-acting HSV helicase-primase inhibitor candidates ABI-5366 and ABI-1179 in participants with recurrent genital herpes, including reported reductions in HSV-2 shedding rates, high viral load shedding and genital lesion rates in certain dosing cohorts. News items also cover Phase 1b data for ABI-4334, a next-generation capsid assembly modulator candidate in chronic HBV infection, and Phase 1a interim data for ABI-6250, an oral HDV entry inhibitor candidate evaluated in healthy participants.
Another key theme in Assembly Bio’s news is its collaboration with Gilead Sciences. Company announcements describe Gilead’s rights to opt in to exclusive licenses for specific programs and report that Gilead has exercised its combined option to license the HSV helicase-primase inhibitor programs ABI-5366 and ABI-1179 for recurrent genital herpes. These items provide context on how the collaboration may influence development responsibilities, potential milestones and royalty structures.
Financial and corporate updates also feature prominently in ASMB news. Quarterly results outline collaboration revenue from Gilead, research and development spending on HSV, HBV and HDV programs, and general and administrative expenses. Additional releases describe equity financings, including an underwritten offering of common stock and warrants and a private placement with Gilead, along with the intended use of proceeds for general corporate purposes.
For investors and observers, the ASMB news feed offers a consolidated view of Assembly Biosciences’ clinical data disclosures, collaboration developments, financing activities and participation in scientific and investor conferences. Bookmarking this page can help track how the company’s antiviral pipeline and partnership with Gilead evolve over time.
Assembly Biosciences (NASDAQ:ASMB) and Gilead Sciences announced Gilead exercised its option to exclusively license Assembly Bio’s HSV helicase-primase inhibitor programs, ABI-1179 and ABI-5366, for recurrent genital herpes on December 22, 2025. Assembly Bio will receive a $35 million payment reflecting an option fee net of prior accelerated funding. Gilead gains sole U.S. development and commercialization rights; Assembly Bio remains eligible for up to $330 million in milestones plus tiered royalties and a U.S. opt-in to share 40% of costs and profits.
Both candidates showed positive Phase 1b antiviral and safety data supportive of once-weekly oral dosing.
Assembly Bio (Nasdaq: ASMB) reported positive interim Phase 1b results for two long-acting HSV helicase-primase inhibitor candidates, ABI-1179 (weekly oral) and ABI-5366 (monthly and weekly oral regimens), dated Dec 8, 2025.
Key findings: 50 mg weekly ABI-1179 showed a 98% reduction in HSV-2 shedding, > 99% reduction in high viral load swabs and 91% reduction in virologically confirmed genital lesion rate vs placebo over 29 days; ABI-5366 monthly cohort showed 76% shedding and 88% lesion rate reductions. Both candidates were generally well tolerated and PK supports weekly and potentially monthly dosing.
Assembly Biosciences (Nasdaq: ASMB) reported Q3 2025 results and program updates on Nov 10, 2025. Key clinical highlights include positive Phase 1b interim results for ABI-5366 showing significant reductions in HSV-2 shedding and genital lesions, and Phase 1a data for ABI-6250 supporting once-daily dosing and progression to Phase 2. Enrollment completed for ABI-5366 and two ABI-1179 cohorts; an HSV data readout is now expected by year-end and a Phase 2 start for ABI-5366 is anticipated mid-2026.
Financials: the company raised $175M in equity, held $232.6M cash at Sept 30, 2025 (runway into late 2027), reported Q3 revenue from Gilead collaboration of $10.8M, R&D $16.6M, and net loss of $9.2M.
Assembly Biosciences (Nasdaq: ASMB) presented positive Phase 1b data for its next‑generation capsid assembly modulator ABI‑4334 at AASLD The Liver Meeting® on Nov 7, 2025.
The randomized, blinded Phase 1b evaluated oral once‑daily 150 mg and 400 mg doses for 28 days in predominantly HBeAg‑negative chronic hepatitis B patients. ABI‑4334 was reported as well tolerated at both doses, produced multi‑log declines in HBV DNA and pgRNA, and achieved exposures multiple‑fold above levels anticipated to inhibit cccDNA formation. As expected for the population and short dosing interval, no reductions in HBsAg were observed. Under a collaboration, Gilead has a post‑study option to obtain an exclusive license for further development of ABI‑4334.
Assembly Biosciences (Nasdaq: ASMB) will participate in two investor conference fireside chats in October–November 2025.
Anuj Gaggar, MD, PhD, chief medical officer, will appear in a pre-recorded fireside chat available on demand beginning October 21, 2025 at 7:00 AM ET during the H.C. Wainwright Liver Disease Virtual Conference.
Jason Okazaki, CEO and president, and Dr. Gaggar will present a live fireside chat on November 12, 2025 at 11:00 AM ET at the Guggenheim 2nd Annual Healthcare Innovation Conference. Webcasts and replays will be available via the company's Events and Presentations page.
Assembly Bio (Nasdaq: ASMB) presented interim Phase 1b data for long‑acting HSV helicase‑primase inhibitor ABI‑5366 at IUSTI Europe on Oct 10, 2025. In the 350 mg weekly cohort, ABI‑5366 showed statistically significant reductions versus placebo: HSV‑2 shedding rate −94%, high viral load shedding −98%, and genital lesion rate −94%. ABI‑5366 was reported as well tolerated at evaluated doses and pharmacokinetics support weekly and potentially monthly dosing. A monthly regimen and data on ABI‑1179 are being evaluated with additional interim results expected later this fall. Assembly Bio plans to initiate Phase 2 studies of ABI‑5366 in mid‑2026.
Assembly Biosciences (Nasdaq: ASMB) has announced the pricing of two equity financings totaling $175 million. The company is conducting an underwritten public offering of 5,591,840 shares of common stock and 1,040,820 pre-funded warrants, along with accompanying Class A and Class B warrants, at $19.60 per share.
Additionally, Gilead Sciences will participate through a private placement, purchasing 2,295,920 shares with accompanying warrants. Notable investors include Commodore Capital, Blackstone Multi-Asset Investing, Farallon Capital Management, Janus Henderson Investors, and RA Capital Management. The transactions are expected to close on August 11, 2025.
Assembly Biosciences (NASDAQ:ASMB) reported positive interim results from its Phase 1b study of ABI-5366, a long-acting helicase-primase inhibitor for recurrent genital herpes. The 350mg weekly oral dose demonstrated remarkable efficacy with a 94% reduction in HSV-2 shedding rate and genital lesion rate compared to placebo over a 29-day period.
Key highlights include a 98% reduction in high viral load shedding rate and favorable safety profile. The pharmacokinetic profile supports potential for both weekly and monthly dosing regimens. Assembly Bio plans to advance directly to Phase 2 clinical studies, expected to initiate in mid-2026.
Under their collaboration agreement, Gilead Sciences maintains the right to opt in for exclusive licensing following completion of Phase 1b studies.
Assembly Biosciences (NASDAQ: ASMB) reported Q2 2025 financial results and clinical progress across its viral disease pipeline. The company ended Q2 with $75.0 million in cash, projecting operations funding into mid-2026. Revenue from Gilead collaboration increased to $9.6 million, while net loss improved to $10.2 million ($1.33 per share).
Key clinical developments include: positive Phase 1b results for ABI-4334 in chronic HBV patients, interim data from ABI-6250's Phase 1a study showing target engagement for HDV treatment, and advancement of ABI-5366 and ABI-1179 trials for genital herpes, with proof-of-concept data expected by fall 2025. The company initiated U.S. site expansion for ABI-1179's Phase 1b trial following IND clearance.
Assembly Biosciences (Nasdaq: ASMB) has reported promising interim Phase 1a data for ABI-6250, their oral hepatitis delta virus (HDV) entry inhibitor candidate. The study demonstrated a four-day half-life, supporting once-daily oral dosing, and showed dose-dependent elevations in total serum bile acids, indicating effective target engagement.
Key findings include successful completion of two single-dose cohorts (5mg and 25mg) and three multiple-dose cohorts (0.05mg, 0.2mg, and 1mg). Safety data showed mostly Grade 1 adverse events, with one Grade 2 ALT elevation in the highest dose cohort. All ALT elevations were self-limited without signs of liver injury.
The company plans to conduct additional pharmacological assessment while preparing for Phase 2 studies, positioning ABI-6250 as potentially the first oral therapy for chronic HDV infection.
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